Risperidone Viatris 1 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Risperidone Viatris 1 mg/ml oral solution EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Risperidone Viatris is and what it is used for.

2. What you need to know before taking Risperidone Viatris

3. How to take Risperidone Viatris

4. Possible side effects

5. How to store Risperidone Viatris

6. Contents of the pack and other information

1. What Risperidone Viatris is and what it is used for

Risperidone Viatris belongs to a group of medicines called "antipsychotics".

Risperidone Viatris is used to treat the following conditions:

• Schizophrenia, in which you may see, hear, or feel things that are not there, believe things that are not true, or feel particularly suspicious or confused.
• Mania, in which you may feel overly excited, elated, agitated, enthusiastic, or hyperactive. Mania occurs in a condition called "bipolar disorder".
• Short-term treatment (up to 6 weeks) of persistent aggression in people with Alzheimer's type dementia who harm themselves or others. Alternative non-pharmacological treatments should have been tried previously.
• Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorders.

Risperidone Viatris can help reduce the symptoms of your illness and help prevent them from returning.

2. What you need to know before taking Risperidone Viatris

Do not take Risperidone Viatris

• If you are allergic to risperidone or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Risperidone Viatris if:

• You are taking furosemide (a diuretic used to reduce swelling and fluid retention caused by various medical conditions, including heart or liver disease).
• You have any heart problems. Examples include: irregular heartbeat, weakness of the heart muscle (heart failure), previous heart attack, or if you are prone to low blood pressure or are taking medications for blood pressure. Risperidone may lower blood pressure. You may need a dose adjustment.
• You have any risk factors that may make you prone to stroke, such as high blood pressure, cardiovascular disease, or blood vessel problems in the brain.
• You have any risk factors that may make you prone to developing blood clots, such as current or past smoking, or if you are likely to remain immobile for prolonged periods (for example, after surgery or illness).
• You or a family member has a history of blood clots, as medicines like this have been associated with clot formation.
• You have or have had a low white blood cell count, particularly if this occurred while taking other medications.
• You have ever experienced involuntary movements of the tongue, mouth, or face.
• You have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson’s disease (a brain disorder affecting movement such as tremors, rigid posture, slow movements, and shuffling gait) or dementia (a general decline in intellectual ability such as memory loss and other mental faculties), particularly Lewy body dementia (an abnormal protein aggregate found within neurons in Parkinson’s disease).
• You are diabetic or at risk of developing diabetes (you may have high blood sugar levels).
• You have epilepsy.
• You are male and have ever had a prolonged or painful erection.
• You have difficulty regulating your body temperature or feel excessive heat.
• You have dehydration or low blood volume (hypovolemia), either before or during treatment.
• You have low levels of potassium or magnesium in your blood.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone prolactin in your blood or if you have a tumor that may be prolactin-dependent.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before starting risperidone.

During treatment

Risperidone may cause changes in white blood cell count, which help fight infections, so your doctor may perform blood tests before and during treatment.

Risperidone may cause weight gain. Significant weight gain may negatively affect your health. Your doctor should monitor your body weight periodically.

Since an increased occurrence of diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking risperidone, your doctor should check for signs of high blood glucose levels. In patients with a history of diabetes mellitus, blood glucose levels should be monitored regularly.

It is common for risperidone to increase levels of a hormone called “prolactin.” This may cause adverse effects such as menstrual disorders or fertility problems in women, breast enlargement in men, decreased libido, impotence, and spontaneous milk secretion from the mammary glands (see “Possible side effects”). If such adverse effects occur, blood prolactin levels should be evaluated.

If you are scheduled for eye surgery, inform your doctor or hospital staff that you are taking this medicine. During cataract surgery (clouding of the eye’s lens), this medicine could affect the pupil or iris (the colored part of the eye) and cause eye injury.

Elderly patients with dementia

In elderly patients with dementia, there is an increased risk of stroke (also known as transient ischemic attack or TIA). You should not take risperidone if your dementia is caused by a stroke. While being treated with risperidone, you should see your doctor frequently.

If you or your caregiver notice a sudden change in your mental state or sudden onset of weakness or numbness in the face, arms, or legs—especially on one side—or if you speak unclearly, even briefly, seek immediate medical attention. These may be signs of a stroke.

Children and adolescents

Other causes of aggressive behavior should be ruled out before starting treatment for conduct disorders.

Before starting treatment, your child’s body weight should be measured and monitored periodically.

If you experience fatigue during treatment with risperidone, changing the time of administration may improve difficulties with attention.

A small inconclusive study has shown an increase in height in children treated with risperidone, but it is unknown whether this is due to the drug’s effect or other factors.

Other medicines and Risperidone Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important to talk to your doctor or pharmacist if you are taking any of the following:

• Medicines that act on the brain, such as those used to calm you (benzodiazepines), or some pain medicines (opioids), allergy medicines (some antihistamines), as risperidone may increase their sedative effect.
• Medicines that can alter the electrical activity of your heart, such as those used for malaria (quinine, mefloquine), heart rhythm disorders (such as quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), allergies (antihistamines), some antidepressants, tetracyclic antidepressants (such as maprotiline), or other medicines for mental disorders.
• Medicines that cause slow heart rate, such as beta-blockers or verapamil (used to treat high blood pressure or angina).
• Medicines that cause low potassium levels in the blood (e.g., certain diuretics).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics used for heart problems or to treat swelling in parts of the body due to fluid retention (such as furosemide or hydrochlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• Rifampicin (a medicine used to treat certain infections).
• Carbamazepine, phenytoin (medicines for epilepsy).
• Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone:

• Quinidine (used for certain types of heart disease).
• Antidepressants such as paroxetine, fluoxetine, sertraline, fluvoxamine, and tricyclic antidepressants (such as amitriptiline).
• Medicines known as beta-blockers and verapamil (used to treat high blood pressure).
• Phenothiazines, oral paliperidone (e.g., used to treat psychosis or as sedatives).
• Cimetidine, ranitidine (stomach acid blockers).
• Itraconazole and ketoconazole (medicines for fungal infections).
• Certain medicines used in the treatment of HIV/AIDS, such as ritonavir.

If you start or stop taking these medicines, you may need a different dose of risperidone.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before using risperidone.

Taking Risperidone Viatris with alcohol

You should avoid consuming alcohol while taking risperidone.

Pregnancy, breastfeeding and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take it.
• The following symptoms may occur in newborns of mothers who took risperidone during the last trimester of pregnancy (last three months): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor immediately.
• Risperidone may increase levels of a hormone called “prolactin,” which may affect fertility in women or men (see section 4 Possible side effects).

Driving and using machines

Dizziness, fatigue, and vision problems have been reported during treatment with risperidone. Do not drive or operate tools or machinery without first consulting your doctor.

Risperidone Viatris contains benzoic acid (E-210)

This medicine contains 1.5 mg of benzoic acid per ml of oral solution. Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Risperidone Viatris

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is as follows:

For the treatment of schizophrenia

Adults

• The initial dose is 2 mg per day, which may be increased to 4 mg per day on the second day.
• Your doctor may adjust your dose depending on how you respond to treatment.
• Most people do well with daily doses of 4 mg to 6 mg.
• This total daily dose can be divided into one or two doses per day. Your doctor will tell you which dose is best for you.

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Your doctor may gradually increase your dose later to 1 mg to 2 mg twice daily.
• Your doctor will tell you which dose is best for you.

For the treatment of mania

Adults

• The initial dose is usually 2 mg once daily.
• Your doctor may gradually adjust your dose depending on your response to treatment.
• Most people do well with daily doses of 1 mg to 6 mg.

Elderly patients

• The initial dose is usually 0.5 mg twice daily.
• Your doctor may gradually adjust your dose to 1 mg to 2 mg twice daily depending on your response to treatment.

For the long-term treatment of aggression in patients with Alzheimer-type dementia

Adults (including elderly patients)

• The initial dose is usually 0.25 mg twice daily.
• Your doctor may gradually change your dose depending on your response to treatment.
• Most people do well with a dose of 0.5 mg twice daily. Some patients may require 1 mg twice daily.
• The duration of treatment in patients with Alzheimer-type dementia should not exceed 6 weeks.

Use in children and adolescents

• Children and adolescents under 18 years of age should not be treated with Risperidone Viatris for schizophrenia or mania.

For the treatment of behavioural disorders in children and adolescents

The dose will depend on your child's weight:

If they weigh less than 50 kg

• The initial dose is usually 0.25 mg once daily.
• The dose may be increased every other day in increments of 0.25 mg per day.
• The usual maintenance dose is 0.25 mg to 0.75 mg once daily.

If they weigh 50 kg or more

• The initial dose is usually 0.5 mg once daily.
• The dose may be increased every other day in increments of 0.5 mg per day.
• The usual maintenance dose is 0.5 mg to 1.5 mg once daily.

The duration of treatment in patients with behavioural disorders should not exceed 6 weeks.

Children under 5 years of age should not be treated with risperidone for behavioural disorders.

Patients with liver or kidney problems

Regardless of the condition being treated, all initial and subsequent risperidone doses should be reduced by half. Dose increases should be made more slowly in these patients.

Risperidone should be used with caution in this patient group.

How to take Risperidone Viatris

Your doctor will tell you how much medicine to take and for how long. This depends on your illness and varies from person to person.

The oral solution comes with a syringe (pipette). Use only the syringe supplied with this medicine to measure the prescribed dose. Measure the exact dose needed. Pay close attention when measuring a small dose; for example, for 0.25 mg, measure 0.25 ml (a quarter of a millilitre); for 0.5 mg, measure 0.5 ml (half a millilitre).

Follow these steps:

1. Remove the child-resistant cap. Push down on the plastic cap while turning it counterclockwise (Figure 1).
2. Insert the syringe into the bottle (Figure 2).
3. While holding the lower ring of the syringe, pull the upper ring upwards to the mark corresponding to the number of millilitres or mg you need to take (Figure 3).
4. Holding the neck of the bottle, remove the entire syringe from the bottle (Figure 4).
5. Empty the syringe into a non-alcoholic drink by sliding the upper ring down (Figure 5).
6. Close the bottle (Figure 6).
7. Rinse the syringe with water and allow it to air dry (Figure 7).

If you take more Risperidone Viatris than you should

• Contact your doctor immediately. Take the medicine pack with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
• In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, or have irregular heartbeat or seizures.

If you forget to take Risperidone Viatris

• If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and continue with your regular schedule. If you miss two or more doses, contact your doctor.
• Do not take a double dose (two doses at the same time) to make up for forgotten doses.

If you stop taking Risperidone Viatris

Do not stop taking this medicine unless your doctor tells you to. Symptoms may return or you may experience nausea, vomiting, sweating, difficulty sleeping, and involuntary movement disorders. If your doctor decides to discontinue treatment, your dose may be gradually reduced over several days.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately or go to a hospital emergency department if you experience any of the following adverse effects:

Common (may affect up to 1 in 10 people):

• Development of lung infections, including serious lung infections such as pneumonia – you may experience an increase in body temperature, cough with mucus, which may be bloody or frothy, and feel very unwell.

Uncommon (may affect up to 1 in 100 people):

• Sudden weakness or numbness of the face, arms or legs, especially on one side, episodes of vision problems or difficulty speaking lasting less than 24 hours. These may be signs of a mini-stroke (transient ischaemic attack, TIA), stroke, or reduced blood flow to the brain.
• Abnormal heart rhythm, such as palpitations (fibrillation), very slow or irregular heartbeat (heart block). These may be caused by abnormal electrical conduction in the heart and may be detected as an abnormality in the heart's electrical activity (electrocardiogram or ECG). In some cases, this may be potentially fatal.
• Lack of response to stimuli (changes in internal or external environment), decreased consciousness or loss of consciousness, or seizures.
• Involuntary rhythmic movements of the tongue, mouth and face. Discontinuation of risperidone may be necessary.
• Development of diabetes – occurs when the body is unable to properly regulate blood sugar levels. You may feel very thirsty, need to urinate frequently, have increased appetite, feel tired and drowsy. If untreated, you may fall into a coma or develop complications from uncontrolled diabetes.
• Infections with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat or mouth sores. Risperidone may cause a significant decrease in the number of white blood cells in the blood and, as a result, reduce your resistance to infections. Blood tests will be performed to check for a possible reduction in white blood cells. It is important to inform your doctor that you are taking this medicine.
• Lung infection caused by food entering the airways, lung congestion (e.g., due to mucus buildup).
• Skin infection, usually in the thighs and buttocks (cellulitis).
• Inability to urinate or incomplete bladder emptying.
• Severe constipation, which may be due to intestinal obstruction or hardening and compaction of stools.

Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction causing difficulty breathing and shock, swollen face, sudden swelling of the lips and eyes, tongue or throat, difficulty swallowing, hives, and low blood pressure.
• Unexplained muscle pain, muscle cramps or muscle weakness (rhabdomyolysis).
• Blood clots in the veins, especially in the legs (symptoms include leg swelling, pain and redness), which may travel through blood vessels to the lungs and cause chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Fever, muscle stiffness, sweating or decreased level of consciousness (a disorder called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• Prolonged or painful erection, called priapism. Immediate medical treatment may be required.
• Abdominal pain radiating to the back. This may be a symptom of pancreas inflammation.
• Increased eye pressure (glaucoma), which may cause vision problems and serious long-term vision problems.
• Decrease in normal blood sodium levels, which may make you feel weak, confused and experience muscle pain. This may be due to inappropriate secretion of the hormone (ADH), causing the body to retain water and dilute the blood, reducing sodium levels. It may be associated with excessive intake of large amounts of water (more than 2 litres of water per day).

Very rare (may affect up to 1 in 10,000 people):

• Loss of appetite, unexplained weight loss, nausea, vomiting, stomach pain, difficulty breathing, slow heart rate, unusual muscle pain or feeling of weakness, fatigue or discomfort. These may be signs of a potentially fatal, infrequent complication of uncontrolled diabetes, called diabetic ketoacidosis.

The following adverse effects may also occur:

Very common (may affect more than 1 in 10 people):

• Parkinsonism. This is a medical term that includes several symptoms. Each individual symptom may occur less frequently than 1 in 10 people. Parkinsonism includes: increased salivation or very wet mouth, musculoskeletal rigidity, drooling, pain when bending limbs, slowed, reduced or difficult body movements, lack of facial expression, muscle tightness, torticollis, muscle stiffness, short, shuffling steps when walking, dragging feet, absence of normal arm movements, persistent blinking in response to tapping the forehead (an abnormal reflex).
• Headache, difficulty falling or staying asleep.
• Drowsiness, somnolence.

Common (may affect up to 1 in 10 people):

• Fatigue, tiredness, inability to remain still, anxiety, drowsiness, depression, agitation, dizziness, feeling of exhaustion, sleep disturbance.

• Vomiting, diarrhoea, constipation, nausea, heartburn or indigestion, abdominal pain or discomfort, sore throat, dry mouth, toothache.

• Weight gain, increased body temperature, increased appetite, decreased appetite.

• Shortness of breath, flu, blurred vision, eye infection or allergic reactions in the eyes which may produce sticky discharge, sinus infections, nasal congestion, nosebleeds, cough.

• Urinary tract infection, bedwetting, inability to control urine flow (incontinence).

• Tremor, muscle cramps, involuntary movements of the face or arms and legs, repetitive movements or abnormal postures associated with muscle contractions, muscle and joint pain, back pain.

  • Fluid retention in the body (e.g., swelling of arms and legs), pain in arms and legs.

• Rash, redness of the skin, ear infections.

• Rapid heartbeat, chest pain, increased blood pressure.

• Falls.

• Increased concentration of the hormone prolactin in the blood.

Uncommon (may affect up to 1 in 100 people):

• Excessive water intake, thirst, faecal incontinence, flatulence, hoarseness or voice disorder.

  • High blood sugar levels.

• Bladder infection, viral infection and other infections, tonsil infection, stomach infection, eye discharge, fungal nail infection.

• Drop in blood pressure upon standing, low blood pressure, dizziness when changing position, awareness of heartbeat, slow heartbeat.

• Pain when urinating, frequent urination.

• Confusion, attention disorder, excessive sleepiness, nightmares, nervousness, elevated mood (mania).

• Increased liver enzymes, decreased haemoglobin or number of red blood cells (anaemia), increased number of eosinophils (special white blood cells), increased creatine phosphokinase, decreased number of platelets (blood cells that help stop bleeding), increased blood cholesterol.

• Muscle weakness, excessive restlessness associated with muscle spasms and tremor, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, chest discomfort.

• Skin injury, skin disorder, dry skin, severe itching, acne, hair loss, eczema (skin inflammation), which may be due to mites, skin discoloration, skin thickening, flushing, sensation of pins and needles, reduced skin sensitivity to pain or touch, inflammation of oily skin.

• Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, breast enlargement in males, breast pain or discomfort, decreased sexual desire, irregular or delayed menstruation, vaginal discharge.

• Fainting, gait disorder (walking pattern), inactivity, weight loss, reduced appetite with malnutrition and weight loss, feeling of "malaise", balance disorder, allergy, chills, coordination abnormality, taste disturbances.

• Painful sensitivity to light, increased blood flow to the eye, dry eyes, increased tearing.

• Crackling lung sounds, speech problems, difficulty swallowing, hoarse or wheezing breathing sounds.

• Ringing in the ears, sensation of movement and dizziness (vertigo), facial swelling.

Rare (may affect up to 1 in 1,000 people):

• Inability to achieve orgasm, breast enlargement, breast tenderness and swelling.

• Dandruff.

• Coldness in arms and legs, tongue swelling, lip swelling, hardening of body parts such as skin.

  • Absence of movement or response while awake (catatonia).
  • Sleepwalking.
  • Sleep-related eating disorder.

• Crusting at the edge of the eyelid, eye movement, problems with eye movement, complications during cataract surgery.

• Absence of emotions.

• Medication withdrawal syndrome.

  • Decreased body temperature.

• Rapid and shallow breathing, breathing problems during sleep, sinus arrhythmia (a normal variation in heart rhythm caused by breathing).

• Movement disorder.

• Head tremor.

• Yellowing of the skin and eyes (jaundice).

• Presence of blood sugar (glucose) in the urine, low blood sugar levels, elevated levels of insulin and fats (triglycerides) in the blood.

Very rare (may affect up to 1 in 10,000 people):

• Intestinal obstruction (persistent constipation accompanied by stomach swelling and vomiting).

The following adverse effects have been reported with use of another medicine called paliperidone, which is very similar to risperidone; therefore, they are also expected to occur with risperidone: rapid heartbeat upon standing.

Not known: Frequency cannot be estimated from the available data

• Severe or potentially fatal skin rash with blisters and skin peeling that may start in or around the mouth, nose, eyes and genitals and spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

Other adverse effects in children and adolescents

In general, adverse effects in children are expected to be similar to those observed in adults.

The following adverse effects were reported more frequently in children and adolescents (5 to 17 years) than in adults: feeling drowsy or less alert, fatigue (tiredness), headache, increased appetite, vomiting, symptoms of common cold, nasal congestion, abdominal pain, dizziness, cough, fever, tremor (shakiness), diarrhoea and urinary incontinence (lack of control).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack or on the bottle, after CAD or EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C. Do not refrigerate or freeze. Store in the original packaging.

Once the bottle has been opened, any unused portion must be discarded after 4 months.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risperidone Viatris

The active substance is risperidone. Each ml of oral solution contains 1 mg of risperidone.

The other components are tartaric acid (E334), benzoic acid (E210), hydrochloric acid, and purified water.

Appearance of the product and contents of the pack

The oral solution is clear and colourless. It is available in amber glass bottles with a child-resistant cap, containing 30 ml, 60 ml, 100 ml, and 120 ml.

A syringe (pipette) is included to facilitate accurate measurement. A pipette cleaner is also provided.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Chanelle Medical Unlimited Company
Dublin Road, Loughrea, County Galway
Ireland

or

McDermott Laboratories Ltd. t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany: Risperidon dura 1 mg/ml Lösung zum Einnehmen
Spain: Risperidona Viatris 1 mg/ml oral solution EFG
Italy: Risperidone Mylan Generics
Netherlands: Risperidon drank Viatris 1 mg/ml, drank
Portugal: Risperidona Mylan 1 mg/ml, soluçaö oral

Date of the most recent review of this leaflet: November 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/